MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ART. SURF. FIXED BEARING (UC) RIGHT 12 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Adhesion(s) (1695)

Event Date 12/09/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 medical devices: persona femur cemented (cr) standard right size 10 catalog#: 42502606802 lot#: 65439658 all-poly patella cemented 38 mm diameter catalog#: 42540200038 lot#: 65459863 tibia cemented 5 degree stemmed right size g catalog#: 42532007902 lot#: 65434010 stem extension tapered cemented 14 mm diameter +30 mm length catalog#: 42557000114 lot#: 65890763.Palacos r + g (1x40) catalog#: 66022663 lot#: 64881208.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.

Event Description

It was reported that patient underwent a right knee revision approximately seven months post-implantation due to stiffness and adhesions.No additional patient consequences were reported.

• Brand Name: PERSONA ART. SURF. FIXED BEARING (UC) RIGHT 12 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19173929
• MDR Text Key: 340941938
• Report Number: 3007963827-2024-00144
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024243132
• UDI-Public: (01)00889024243132(17)250913(10)64877274
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42522200612
• Device Lot Number: 64877274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2023
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male